Ažuriranje podataka o prožimanju zaštitnih medicinskih rukavica antineoplastičnim lijekovima

Occupational exposure to antineoplastic drugs (ADs) handling and administration is one of the main risks in the healthcare sector. Dermal absorption represents the primary route of exposure to ADs. Personal preventive equipment, especially medical gloves, is crucial to safeguard the workers health in ADs handling; thus, chemicals permeating through protective materials is an essential aspect to estimate and consider. Several studies on permeation through medical gloves reported that breakthrough time and permeation rate are the values that must be studied, observing that physical-chemical properties of drugs, PPE materials and thickness, and temperature are crucial features to estimate them. In the European Union, standardized permeation testing is not mandatory for gloves used in ADs manipulation, in contrast with the United States, that proposed stringent requirements in the American Society of Testing and Materials International standard D6978-05. This review would help identify the main characteristics of the best protective glove used by employees frequently exposed to ADs: the major aspects implicated in permeation, reported in the literature, are listed and discussed.Radna izloženost rukovanju i primjeni antineoplastičnih lijekova (AD) jedan je od glavnih rizika u zdravstvenom sektoru. Kožna apsorpcija predstavlja primarni put izlaganju AD-ima. Osobna preventivna oprema, posebno medicinske rukavice, presudna je za zaštitu zdravlja radnika u radu s AD-ima; prema tome, kemikalije koje prodiru kroz zaštitne materijale bitan su aspekt za procjenu i razmatranje. Nekoliko studija o prožimanju kroz medicinske rukavice izvijestilo je da su vrijeme proboja i brzina prodiranja vrijednosti koje se moraju proučavati, primjećujući da su fizičko-kemijska svojstva lijekova, OZO materijali i debljina i temperatura ključne značajke za njihovu procjenu. U Europskoj uniji, standardizirano ispitivanje prožimanja nije obvezno za rukavice koje se koriste u manipulaciji ADs, za razliku od Sjedinjenih Država koje su predložile stroge zahtjeve u međunarodnom standardu D6978-05 Američkog društva za ispitivanje i materijale. Ovaj pregled pomogao bi identificirati glavne karakteristike najbolje zaštitne rukavice koju koriste zaposlenici često izloženi AD-ima: glavni aspekti uključeni u prožimanje, priopćeni u literaturi, navedeni su i raspravljeni

A Qualitative and Quantitative Occupational Exposure Risk Assessment to Hazardous Substances during Powder-Bed Fusion Processes in Metal-Additive Manufacturing

Metal-additive manufacturing (AM), particularly the powder-bed fusion (PBF) technique, is undergoing a transition from the short-run production of components to higher-volume manufacturing. The industry’s increased production efficiency is paired with a growing awareness of the risks related to the inhalation of very fine metal powders during PBF and AM processes, and there is a pressing need for a ready-to-use approach to assess the risks and the occupational exposure to these very final metal powders. This article presents a study conducted in an AM facility, which was conducted with the aim to propose a solution to monitor incidental airborne particle emissions during metal AM by setting up an analytical network for a tailored approach to risk assessment. Quantitative data about the respirable and inhalable particle and metal content were obtained by gravimetric and ICP-MS analyses. In addition, the concentrations of airborne particles (10–300 nm) were investigated using a direct reading instrument. A qualitative approach for risk assessment was fulfilled using control banding Nanotool v2.0. The results show that the operations in the AM facility are in line with exposure limit levels for both micron-sized and nano-sized particles. The particulate observed in the working area contains metals, such as chromium, cobalt, and nickel; thus, biological monitoring is recommended. To manage the risk level observed for all of the tasks during the AM process, containment and the supervision of an occupational safety expert are recommended to manage the risk. This study represents a useful tool that can be used to carry out a static evaluation of the risk and exposure to potentially harmful very fine metal powders in AM; however, due to the continuous innovations in this field, a dynamic approach could represent an interesting future perspective for occupational safety

Developing a Fast Ultra-High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method for High-Throughput Surface Contamination Monitoring of 26 Antineoplastic Drugs

Growing attention on carcinogenicity and mutagenicity of antineoplastic drugs (ADs) from the International Agencies has led to the present strict safe handling and administration regulations. Accordingly, one of the most common ways to assess occupational exposure to these substances is to identify and quantify possible surface contamination inside hospital preparation and administration units. Thus, it is essential to develop a fast and high-throughput monitoring method capable of identifying a significant number of ADs. The present study reports developing a UHPLC–MS/MS analysis to screen 26 ADs surface contamination through wipe test sampling. A Cortecs UPLC T3 50 × 2.1 mm (1.6 µm) column was selected to perform the analysis, using the evaluations of previous studies and the Product Quality Research Institute (PQRI) database. The design of experiments (DoE) methodological approach was used to optimize the chromatographic conditions concerning the best separation between all ADs. The limits of quantification for the analytes were between the pg/mL and ng/mL orders, and the turnaround time was limited to about 15 min. The obtained accuracy was mostly between 90% and 110% for all the analytes, while the precision was under 10% and a low matrix effect was observed for said analytes. Only vindesine and docetaxel presented lower performances

Characterization and Separation of Platinum-Based Antineoplastic Drugs by Zwitterionic Hydrophilic Interaction Liquid Chromatography (HILIC)–Tandem Mass Spectrometry, and Its Application in Surface Wipe Sampling

Platinum-based antineoplastic drugs (PtADs) are among the most important and used families of chemotherapy drugs, which, even showing severe side effects and being hindered by drug resistance, are not likely to be replaced clinically any time soon. The growing interest in the occupational health community in antineoplastic drug (AD) surface contamination requires the development of increasingly fast and easy high-throughput monitoring methods, even considering the lack of harmonized legally binding regulation criteria. Thus, a wipe sampling method together with zwitterionic hydrophilic interaction liquid chromatography (HILIC-Z)–tandem mass spectrometry (MS/MS) analysis was developed for the simultaneous evaluation of oxaliplatin, cisplatin, and carboplatin surface contaminations. A design of experiments approach was used to optimize the chromatographic conditions. Limits of quantification ranging from 2 to 5 ng/mL were obtained from interday and intraday repetitions for oxaliplatin and carboplatin, and between 170 and 240 ng/mL for cisplatin. The wipe desorption procedure is equivalent to other AD sampling methods, enabling a fast sample preparation, with an LC-MS/MS analysis time of less than 7 min

A Qualitative and Quantitative Occupational Exposure Risk Assessment to Hazardous Substances during Powder-Bed Fusion Processes in Metal-Additive Manufacturing

Metal-additive manufacturing (AM), particularly the powder-bed fusion (PBF) technique, is undergoing a transition from the short-run production of components to higher-volume manufacturing. The industry’s increased production efficiency is paired with a growing awareness of the risks related to the inhalation of very fine metal powders during PBF and AM processes, and there is a pressing need for a ready-to-use approach to assess the risks and the occupational exposure to these very final metal powders. This article presents a study conducted in an AM facility, which was conducted with the aim to propose a solution to monitor incidental airborne particle emissions during metal AM by setting up an analytical network for a tailored approach to risk assessment. Quantitative data about the respirable and inhalable particle and metal content were obtained by gravimetric and ICP-MS analyses. In addition, the concentrations of airborne particles (10–300 nm) were investigated using a direct reading instrument. A qualitative approach for risk assessment was fulfilled using control banding Nanotool v2.0. The results show that the operations in the AM facility are in line with exposure limit levels for both micron-sized and nano-sized particles. The particulate observed in the working area contains metals, such as chromium, cobalt, and nickel; thus, biological monitoring is recommended. To manage the risk level observed for all of the tasks during the AM process, containment and the supervision of an occupational safety expert are recommended to manage the risk. This study represents a useful tool that can be used to carry out a static evaluation of the risk and exposure to potentially harmful very fine metal powders in AM; however, due to the continuous innovations in this field, a dynamic approach could represent an interesting future perspective for occupational safety

Expanding Antineoplastic Drugs Surface Monitoring Profiles: Enhancing of Zwitterionic Hydrophilic Interaction Methods

Antineoplastic drugs are a wide and heterogeneous group of substances that, as universally known, can cause highly severe toxic effects to whoever is exposed. From an occupational safety point of view, surface contaminations inside preparation and administration units are a growing issue and therefore require the development and implementation of sensible and fast monitoring methods. The unlikelihood of a unique all-embracing chromatography, able to correctly retain and separate each analyte led to the need to create an orthogonal normal phase analysis, which might be able to fill the gaps in the more common reversed-phase ones. An existing hydrophilic interaction method has thus been expanded to 6 other drugs and applied to real samples after an evaluation of its performances. The experimental data were then used to evaluate the possibility of estimating reliable relationships between the chromatographic retention and the chemical-structural features of the drugs under analysis

Untargeted Screening of Per- and Polyfluoroalkyl Substances (PFASs) in Airborne Particulate of Three Italian E-Waste Recycling Facilities

Poly- and perfluorinated alkyl substances (PFASs) are widely used in the electrical and electronic appliance industry to the point that waste of electrical and electronic equipment (WEEE), also known as e-waste, creates significant potential for PFAS exposure (by inhalation, ingestion, or dermal exposure) for people handling and recycling e-waste. The aim of this work was the development of an untargeted analytical approach in order to detect the presence of possible unknown PFASs in particulate matter collected in three Italian e-waste facilities through liquid chromatography coupled to high-resolution tandem mass spectrometry (LC-HR-MS/MS) in negative ionization mode. By means of three acquisition experiments, nine compounds were detected as candidate PFASs, and three were definitively confirmed by comparison with their authentic standards. Among these, bistriflimide (bis (trifluoromethylsulfonyl) imide), an ionic liquid with several promising technological applications, was the most abundant compound detected in all three recycling plants. This is the first study associating the presence of fluorinated ionic liquids with e-waste, and as these chemicals are not only toxic and persistent but also highly mobile, our results indicate the need to include them in future PFAS research. Only further data on their actual environmental diffusion will determine whether they are emerging pollutants or not

Monitoring surface contamination for thirty antineoplastic drugs: a new proposal for surface exposure levels (SELs)

Background Chemotherapy drugs are widely used to treat cancer, but their active compounds represent a danger for workers who could be exposed to them. However, they aren’t yet included in directive CE No. 1272/2008 and the European Biosafety Network has only recommended a limit value of 100 pg/cm2 for surface contamination. Thus, it is crucial to assess surface contaminations in healthcare environments. Currently, the technique of choice is surface wipe test combined with liquid chromatography tandem mass spectrometry to achieve high sensibility. Material and Methods A campaign involving Careggi University Hospital (Florence, Italy) was performed from January 2020 to December 2021, collecting 1449 wipe samples between administration units, preparation unit, and personnel gloves. From the obtained data, the 90th percentile was calculated for 30 antiblastic drugs and proposed as surface exposure levels (SELs); while from data concerning personnel glove contamination, weekly contamination was estimated. Results In the 2-year period only 417 wipe samples were found positive (28.8%), the majority of which regard samples coming from administration unit bathrooms. The proposed SELs are almost all 2, except for few drugs which produce higher contamination on bathroom surfaces. Also, the estimation of pharmacy personnel’s glove contamination highlighted very low results (ng/week). Conclusions Deeply established protocols and procedures for safe handling of ADs allow for obtaining excellent cleaning results and thus a safer work environment, however, the risk of cytostatic contaminations cannot be avoided in healthcare workplaces, and thus a harmonization of classification and labeling of chemotherapy drugs throughout the European Union should be done